Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors

ECD Clinical Trial

Official title:

A 12 Month, Single-center, Open-label, Randomized-controlled Trial to Investigate Efficacy, Safety and Tolerability of Everolimus in Combination With Cyclosporine A and Corticosteroid in de Novo Transplant Recipients of Expanded Criteria Donor Kidneys or Acute Kidney Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02314312
• Other study ID #: CRAD001ATH01T
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 8, 2014
• Last updated: December 10, 2014
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: December 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Single center, open-label randomized-control trial Population: de novo 48 kidney transplant recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation

Description:

Secondary Endpoints:

• To assess renal function by means of eGFR (Cockcrault and Gault formula), at -Month 6 and 12 post-transplantation

• To assess incidence of the individual composite endpoints including BPAR, graft loss and death at Month 6 and 12 post-transplantation

• To assess the incidence and duration of renal replacement therapy

• To assess the incidence of chronic allograft nephropathy (IF/TA) at Month 12

• To assess renal function by means of serum creatinine at Month 6 and 12 post-transplantation

• To compare the overall safety and tolerability (incidence of AEs and SAEs, infections, discontinuations due to AEs, lab abnormalities, wound and surgical complications) at Month 6 and 12 post-transplantation

Definition of ECD

• Brain-dead donor > 60 years old or

• Donor age > 50 years old with two of the following criteria;

• History of HT

• Terminal SCr. ≥ 1.5 mg/dL

• Death from cerebrovascular accident Definition of AKI donor

• Brain-dead donor with an increase of SCr. ≥ 0.3 mg/dL from baseline

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18-75 years

• Recipients of first DDKT from ECD or AKI donors

• Patient willing to participate in the study

Exclusion Criteria:

• Multi-organ recipients

• Organ donation after Cardiac Death (DCD).

• PRA > 20 % or with historical peak PRA > 50%

• Patients who lost first graft due to immunological reason within the first year post-transplantation.

• ABO incompatible transplants or positive cross-match

• Patients with chronic inflammatory bowel disease.

• Severe allergy requiring acute treatment, or any known hypersensitivity to everolimus, thymoglobulin

• Thrombocytopenia (platelet < 75,000/mm3), ANC < 1,500 /mm3 or leucopenia (leucocytes < 2,500/mm3), or Hb < 6 g/dL

• Chronic active HCV, HIV, or HBsAg positive

• History of malignancy during the last five years, except squamous or basal cell carcinoma of the skin.

• Ongoing infection requiring treatment with a systemic antibiotic.

• Patient with severe hypercholesterolemia (> 300 mg/dL) or hypertriglyceridemia (> 600 mg/dL) that cannot be controlled

• Evidence of severe liver disease.

• Severe restrictive or obstructive pulmonary disorders.

• Pregnant or nursing (lactating) women.

• Patient who refuse to participate into the study or would like to withdraw from the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ECD
• Expanded Criteria Donor
• Transplantation of Kidney

Intervention

Drug:
• Everolimus + low dose cyclosporin A + prednisolone

• Standard immunosupressive regimen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eGFR (CKD-EPI)		12 months post kidney transplantation	No